Out of 47 indications granted fast-track status, benefits have not yet been confirmed in 21, mostly because trials are ongoing, according to John R. Johnson, MD, of the FDA's oncology drugs office, and colleagues."Lack of due diligence in conducting confirmatory trials is a serious concern that has threatened the continuation of the accelerated approval process," they wrote online in the Journal of the National Cancer Institute.They noted that the Food, Drug, and Cosmetic Act of 2007 gives the FDA authority to levy penalties of up to $10 million on pharmaceutical companies for not completing trials for fast-tracked drugs quickly enough.